Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The plates incubated with the test item showed normal background growth up to 5000 Lg/plate with and without S9 mix in both experiments. No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FAT 40840/A TE at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.


Short description of key information:
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not
induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

FAT 40840/A E is not classified since the result of the study lies outside the classification criteria